Catheter



Sept. l1, 1962 w. c. BIRTWELL CATHETER Filed Aug. 9, 1960 2 Sheets-Sheet 1 INVENTOR.

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Sept. 11, 1962 w. c. BIRTWELL CATHETER 2 Sheets-Sheet 2 Filed Aug. 9. 1960 United States Patent O 3,053,257 CATHETER William C. Birtwell, North Scituate, RJ., assigner to Davol Rubber Company, Providence, RJ., a corporation of Rhode Island Filed Aug. 9, 1960, Ser. No. 48,489 Claims. (Cl. 12S- 349) The present invention relates to a surgical appliance. More particularly, the present invention relates to a surgical appliance that i-s adapted to facilitate drainage from a cavity, such as the urethra, and has particular reference to a balloon-type catheter.

Prior to the instant invention, catheters have normally been formed of a rubber material. Although rubber is satisfactory for use in some instances as a surgical appliance, it has been found that when a rubber catheter is retained in the urethra tube for an extended period of time, the patients body fluids have a tendency to attack the rubber, thereby causing it to calcify. The heretofore known catheters are also known to be traumatic after periods of indwelling. In normal use the catheter is usually placed in traction by taping it tothe patients leg. When the patient moves, there is a corresponding relative movement of the catheter within the urethra, which movement produces a rubbing effect on the urethra wall to the discomfort of the patient.

The most serious problem in the use of catheters is the effect thereof on the urethra wall when the catheter is removed from the urethra. It is known that in use of the prior known catheters the lubricant applied to the catheter body would dissipate after some period of indwelling, and the catheter therefore had a tendency to adhere to the urethra walls. Thus, when the catheter was removed from the u-rethra, the frictional resistance between the moving catheter body and the urethra wall was -suliicient to produce traumatic results.

The present invention which is designed to overcome the problems heretofore associated with catheters is formed of a plastic material, and since certain plastics are known to be inert, they will resist the deteriorating effects of body fluids, and as a result the catheter may have longer periods of indwelling. The present invention further contemplates utilizing a sleeve of plastic material that envelops the major portion of the catheter body, the sleeve including the usual balloon section formed on the end thereon. The sleeve permits relative movement of the catheter body therein and thereby prevents injury to the urethra walls when the catheter is withdrawn from the urethra. The sleeve also defines with the catheter body an annular passage for introducing a iiuid under presssure into the balloon section, and in one form of the invention includes a chamber Ithat contains the fluid to be introduced into the balloon section. By utilizing the sleeve, the catheter body may be withdrawn from the urethra without injury to the urethra walls, the withdrawing movement being accomplished by peeling the sleeve from the urethra walls. This peeling action is not only less harmful to the urethra than the rubbing normally produced in withdrawing the heretofore known catheters, but enables the catheter to be removed from the urethra with relatively little effort.

The present invention is also designed to eliminate the heretofore known problems normally associated with distensible bag or balloon type catheters and includes a body in which a passage is formed that communicates with the drainage eye of the catheter. Surrounding the body and extending for a major portion thereof in enveloping relation is the sleeve that is formed of a relatively thin exible plastic material, the distal end of lthe sleeve being secured adjacent the drainage eye of the body. The distal end of the sleeve is also formed of a relatively thinner section than the remaining portion thereof, whereby the inflatable or distensible portion is defined that will be deformed upon the introduction of a pressure medium therein. In the distensible balloon sections formed in the catheters heretofore known, the material from which the balloon section was made was normally rubber. Rubber has the characteristic of returning to its original state, and, therefore, upon the withdrawal of the pressure medium therefrom, the extensible portion would return to substantially the same form prior to the distension thereof. In lthe present invention, the material from which the sleeve and distensible portion are formed is plastic. Since plastic will not return to the original state thereof upon withdrawal of the pressure medium, the distensible portion, if it were a standard balloon type, would remain distended, producing a source of trauma around the stem of the catheter. However, with the sliding sleeve type, the distensible portion has a tendency to collapse around the head or distal end of the catheter body. Since the sleeve is only secured to the catheter body adjacent the distal end thereof, the body may be withdrawn from within the sleeve by moving it relatively with respect thereto. Thus as the body is withdrawn from the sleeve, it carries the secured end of the sleeve therewith and, in effect, causes the sleeve to be peeled from the wall of the urethra, the peeling action enabling the sleeve to be conveniently removed from the urethra without any traumatic effects to the patient.

Accordingly, it is an object of the present invention to provide a surgical appliance, such as a balloon-type catheter, which includes an annular wall or sleeve that envelops a major portion of the catheter body.

Another object of the invention is to provide a catheter having an annular wall or sleeve secured to the body portion thereof, the sleeve and body portion having relative movement so that the body portion may be withdrawn from its position of use by removal thereof from the interior of the sleeve.

Still another object is to provide a catheter that is formed of plastic materials which resist the deleterious effects of body fluids when the catheter is located in the urethra.

Still another object is to provide a catheter having an annular sleeve, the annular sleeve permitting relative movement of the catheter body even upon accidental movement of the patient and thereby preventing injury to the urethra in which the catheter has been inserted.

Still another object is to provide a catheter having an annular sleeve formed therearound which includes a balloon section formed at the distal end thereof, the balloon section being distensible by the introduction of a pressure medium into contact therewith.

Still another object is to provide a catheter having an annular chamber located at one end thereof that contains a pressure medium that is adapted to be forced into the balloon section of the catheter for the dis-tending thereof.

Other objects, features and advantages of the invention will become apparent as the description thereof proceeds when considered in connection with the accompanying illustrative drawings.

ln the drawings which illustrate the best mode presently contemplated by us for carrying out our invention:

FIG. 1 is an elevational view of one form of the catheter embodied herein;

FIG. 2 is a vertical sectional View taken along lines 2--2 in FIG. l;

FIG. 3 is a view Vsimilar to FIG. 2 showing the formation of a balloon section adjacent the distal end of the catheter after a pressure medium has been introduced therein;

FIG. 4 is a view similar to FIG. 3 showing the position of the balloon `section after it has `been collapsed upon the removal of the pressure medium therefrom, the body portion of the catheter having been withdrawn to start the peeling disengagement of the annular sleeve from the urethra wall;

FIG. 5 is an elevational view of a modified form of the invention with parts shown in section;

FIG. 6 is a sectional view of the modified form of the invention with parts shown in elevation and illustrating the position of the balloon section after a pressure medium has been introduced thereto;

FIG. 7 is a view similar to FIG. 6 and showing the location `of the catheter body after it has been slidably moved with respect to the annular sleeve whereby the distensible portion of the sleeve has been collapsed around the distal end of the catheter body;

FIG. 8 is a perspective view of one form of a clamp that is utilized in connection with the invention shown in FIGS. 1 through 4; and

FIG. 9 is a perspective view `of one form of a clamp that is used in connection with the modified form of the invention illustrated in FIGS. 5, 6 and 7.

Referring now to the drawings and par-ticularly FIGS. 1 through 4, one form of the invention is illustrated, and it is understood that the catheter embodied herein is adapted to be inserted into a body cavity, such as the urethra, and retained therein for the purpose of draining a body fluid therefrom or, in the alternative, for introducing a fluid therein. As shown in FIGS. l through 4, the catheter embodied herein is generally indicated at 10 and includes an elongated body 12 that is preferably formed of a flexible material, such as plastic. As will be more fully explained hereinafter, plastic materials are preferred because of their inert characteristics and natural resistance to `deterioration caused by contact with body fluids. Formed in the body 12 is a longitudinally extending passage 14 that terminates adjacent the distal end of the body and communicates with a drainage eye 16. The distal end of the body 12 which is indicated at 17 is formed in a generally rounded configuration, as is well known in the art, and serves to permit entry of the catheter into the urethra tube. The proximal end of the body 12 is formed in a flared or funnel shape indicated at 18, the funnel 1S enabling a drainage tube to be easily introduced therein after the catheter has been inserted into the urethra of the patient. Enveloping the body 12 and extending over a major portion thereof is an annular wall or sleeve that includes a balloon section or inflatable portion 22 having a relatively thin wall, the inflatable portion 22 being slightly expanded and having a reverse double-cone configuration. The outer end of the inflatable portion 22 is secured to the distal end of the body 12 as indicated at 24, the securernent of the balloon section to the distal end 17 being accomplished by heating the areas to be secured or by utilizing a suitable adhesive. integrally joined to the proximal end of the sleeve 20 is an enlarged annular tapered section indicated at 26, the ends 2S of the enlarged section being folded inwardly into engaging relation with the body 12 to define an annular seal therewith. Defined by the enlarged section 26 and the annular seal 2S is a chamber indicated at 30 which contains a iiuid, such as a saline solution, therein. Since the sleeve 2.0 is located in enveloping relation around the body 12 and does not engage the body 12 in sealing relation therewith except at the annular seal 28 and at the distal seal 24, an annular passage 32 is defined be-tween the body 12 and sleeve 20 that provides communication between the chamber and the inflatable portion 22.

As mentioned above, the cross section of the wall defining the inflatable portion 22 is reduced with respect to the cross section of the major portion of the sleeve 20 and therefore is relatively Weak. It is seen that upon the introduction of the fluid located in the chamber 30 into contact with the interior surface of the inflatable portion 22, the infiatable portion will distend to form a balloon section, as indicated in FIG. 3. As is well known in the art, the inflatable portion 22 is adapted to retain and hold the catheter 1t? in the position of use when it is inserted into the urethra tube of the patient.

As shown in FIGS. 1 through 4, the fluid that is adapted to enlarge the inflatable portion 22 into the balloon section is wholly contained within the chamber 30, thereby eliminating the need for providing an exterior source of fluid under pressure for distending the inflatable portion 22. As described above, the annular passage 32 provides communication between the chamber 30 and the interior of the inflatable section 22. Thus when the catheter 10 is initially inserted into the urethra of the patient and it is necessary to retain it therein by distendiug the inflatable section 22, the enlarged portion 26 is compressed to force the Huid within the chamber 30 outwardly thereof and through the passage 32 toward the distal end of the annular wall 20. Since the inflatable section 22 is weakened with respect to the relatively large sleeve 2G, it will balloon outwardly as indicated at 34. Any suitable means may be provided for retaining the chamber 30 in the compressed position thereof, and as shown in FIGS. 4 and 8 a spring clamp 36 is employed for this purpose and is snapped around the enlarged portion 26.

In catheters known heretofore, the balloon sections are normally constructed of a rubber material which tends to return to the undistended state upon the release of the pressure medium from contact therewith. In the present invention, the sleeve 2G is formed of a plastic material which has the characteristic of not returning to the original position thereof after being distended under pressure. Thus, when the fluid is removed from the inflatable section .2, it has a tendency to collapse and fall around the distal end 17 of the body 12. As will be described below, this arrangement provides for the safe and easy removal of the catheter from the patient. Oftentimes when the catheter is inserted into a cavity of the patient such as the urethra, the walls of the catheter have a tendency to adhere to the walls of the urethra, and due to surface tension existing therebetween, are not easily disengaged therefrom. By providing that the body 12 is free of any connection with the sleeve 20 except at the sealed end 24 thereof, the body 12 may be moved relative to the sleeve 2f) upon withdrawal of the catheter from the urethra. This unique technique in withdrawal of the catheter enables the body 12 to move rearwardly with respect to the main portion of the sleeve 20, the sealed end of the sleeve following the body 20 during the withdrawal movement thereof. Referring to FIG. 4, the body 12 is shown being withdrawn from the sleeve Ztl, the body 12 having been moved only a portion of the distance necessary to completely withdraw the catheter from the urethra. It is understood that prior to withdrawal the clamp 36 is removed from engagement with the enlarged portion 26, and most of the fluid within the inflatable section 22 is returned to the chamber 3f), thereby releasing the catheter from its locked position within the urethra. Since the distal end of the sleeve 20 is secured directly to the distal end of the body 12, the sleeve 2f) is folded or collapsed over the body 12 as the body is withdrawn from the urethra. It is seen as the body 12 is removed from the urethra, the sleeve 20 will follow and will peelingly dist engage from the wall thereof. As shown in FIG. 4, the peeling action is produced as the secured end of the sleeve moves rearwardly with the body 12, the sleeve in effect turning inside-out. It is understood that the flexible characteristics of the sleeve permit the peeling action while movement of the body 12 with respect to the sleeve 20 is facilitated by the pressure seal 28 that in effect acts as a bearing for the body 12 during the withdrawal thereof from the sleeve 20.

Since the sleeve 20 is peelingly removed from the urethra following the withdrawal of the body 12 rather than being pulled therefrom, relatively little effort is required to effect the withdrawal movement. The peeling action is also the least traumatic to the patient, and this is particularly apparent when it is realized that in prior known catheters withdrawal was accomplished usually after a period of indwelling and after the lubricant therefor had dissipated. in that event, the friction generated between the catheter and the urethra wall as the catheter was withdrawn 'was sufficient to produce Isevere traumatic results. The catheter in `the construction as illustrated is removed from the urethra or any other body cavity without any deleterious effect thereon, and since the inflatable section 22 is completely collapsed around the distal end of the body, protection of the cavity walls is assured as the body 12 and sleeve 20 are slidably and peelingly removed from engagement with the urethra.

Referring now to FIGS. 5, 6 .and 7, a modified form of the invention is illustrated wherein the pressure fluid is adapted to be introduced into the system from an external source. In the modified form of the invention, the Ibody 12 is substantially the same as that disclosed above and includes an annular passage 14 formed therein that -communicates with Ithe distal drainage eye 16. An annular wall or sleeve 38 envelops the major portion of the body 12 andv also includes a reduced section or inflatable portion 39 that is reduced in cross section or weakened with respect to the main portion of the sleeve 38 and thereby is adapted to be ballooned outwardly into a balloon section when a pressure medium is introduced therein. The proximal end of the sleeve 38 is formed in a relatively enlarged annular section 40, the `outer end of wh-ich is rolled inwardly to form an annular seal 42 which is adapted to permit relative movement of the body 12 with respect to the sleeve 38. In order to introduce a pressure medium into the interior of the sleeve 38, a conduit `44 having a passage `formed therein is connected or joined directly to the proximal or enlarged section 40 of the annular wall 38. A funnel porti-on 46 is integrally joined to the conduit 44 and is adapted to receive a tube therein that conveys a fluid under pressure to Ithe conduit 44, the conduit 44 directing the uid under pressure to the enlarged proximal section 40 of -the sleeve 38. The enlarged proximal section 40 of the sleeve 38 also communicates with an annular passage 46 that is defined `between the exterior surface of the body 12 and the interior surface of the sleeve 38, the annular passage 46 providing `for communication between the conduit 44 and `the inflatable section 39.

The uid under pressure is introduced into the tube 44 and directed into the annular passage 46. It is then forced toward the distal end of the catheter and into the inflatable section 39, thereby distending the inatable section outwardly to -form the balloon section as illustrated in FIG. 6. In order to retain the fluid under pressure in the inflatable section, a clamp such as indicated at 48 in FIG. 9 is applied to the conduit 44 and thereby prevents the fluid from escaping therefrom. In this position, the distended section 39 acts to secure the catheter in the urethra tube in which it has been inserted.

'Upon removal of the clamp 48 `from the conduit 44, the fluid under pressure is allowed to escape 'from the inflatable section 39 through the annular passage 46, through the enlarged portion 40 and then through the conduit 44. The inflated section 39 then collapses around the distal end o-f the body 12, and in this position `the catheter is now ready for removal from the urethra into which it has been inserted. As described above in connection with FIGS. 1-4, since the body 1'2 is only connected to the sleeve 38 at the distal end thereof, it will have relative movement with respect to the sleeve, but upon withdrawal therefrom the secured distal end of the sleeve will follow the body. lAs the body 12 moves rearwardly with respect to the sleeve 6 318, the connected distal end thereof will peel from engagement with the wall of the urethra tube. Complete removal of the catheter is effected when the sleeve 38 has been peelingly removed `from the walls of the urethra in which the catheter has been inserted.

As shown in IFIGS. l through 4 andl FIGS. 5 through 7, the annular `seal 42 located at the proximal end of the sleeve not only provides for sliding movement of the catheter body with respect to the sliding wall, but further acts to prevent leakage of the pressure fluid from the sleeve. In a modified form of the invention not show-n in the drawings, it is contemplated that the sleeve be sealed directly to the body 12 in the area of the enlarged portion 42. In this event, prior to removal of the body 12 from the cavity in 'which it has been inserted, the seal 42 together with the catheter will be severed. :I-f the catheter of the type illustrated in FIGS. 1-4 is being used, the fluid in the self-contained construction will be drained when the seal is severed. The vbody 12 is then free for movement with respect to the sleeve, and the body 12 and the sleeve are removed from the body cavity as described above. if this modied form of the invention as described is utilized, it is understood that the catheter is disposable since the proximal end thereof is severed.

The physiological advantage of the present invention is apparent since the body and flexible sleeve of the catheter are 'formed of a plastic material that is re- -sistant to deterioration by body fluids, thereby permitting longer periods of indwelling of the catheter in a body cavity such as the urethra. The flexible sliding wall or sleeve is particularly desirable since movement of the catheter body against the walls of the urethra is prevented when the catheter is in traction. The annular sleeve also has particular application in withdrawal of the catheter from the urethra, and due to the peeling action of the sleeve from the urethra tube, little, if any, trauma occurs.

Since the plastic distended or inflatable section of the sleeve has the characteristic of not returning to its original state upon removal of the inating fluid, the collapsed position of the sleeve `over the distal end of the body portion enables the peeling action to be effected without injuring the walls of lthe urethra during withdrawal of the catheter therefrom.

While there is shown and described herein certain specific structure embodying the invention, it will be manifest to those skilled in the Iart that various modifications and rearrangements of the parts may be made without departing from the `spirit and scope of the underlying inventive concept and that -the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims.

What is claimed is:

1. In a catheter, an elongated body .for insertion into a tube and having a drainage passage therethrough, the distal end of said body having a drainage eye communieating with said drainage passage, a flexible sleeve enveloping the major portion of said body and including a portion adjacent the distal end thereof that is distensible under pressure to form an inflated section, said flexible sleeve being lixedly joined to said body adjacent said drainage eye and being slidably and sealingly engaged with said body adjacent the proximal end thereof, wherein said body is slidable with respect to said sleeve for peeling .said sleeve from the walls of the turbe in which said body has been inserted upon withdrawal of said body from said tube.

2. In a catheter, an elongated body for insertion into a tube and having a drainage passage extending therethrough, a drainage eye formed in the distal end of said body and communicating with said drainage passage, an annular flexible sleeve enveloping the major portion of said body and including a portion adjacent said drainage eye that is distensible for forming a balloon section when a pressure medium is introduced therein, said balloon section being collapsible about the distal end of said body when said pressure medium is removed therefrom, said flexible sleeve being flxedly joined to said body portion adjacent said drainage eye and being slidably and sealingly engaged with said body adjacent the proximal end thereof, said body thereby being slidable with respect to the major portion of said annular sleeve, so that when said body is removed from the tube in which it has been inserted said annular sleeve will be peeled from the walls thereof.

3. In a catheter, an elongated body having a drainage passage extending therethrough, a drainage eye formed in the distal end of said body and communicating with said drainage passage, an annular flexible wall enveloping the major portion of said body and being secured thereto adjacent the distal end thereof, said annular wall engaging an area of said body adjacent the proximal end thereof in sliding and sealing relation therewith, the portion of said annular wall adjacent the distal end of said body being distensible for forming a balloon section when a pressure medium is introduced into contact therewith, said balloon section being collapsible about the distal end of said body when said pressure medium is removed therefrom, said body being slidable with respect to the enveloping portion of said annular wall for carrying the secured part therewith upon the slidable movement thereof, so that when said body is removed from the tube in which it has been inserted, said annular wall is peeled from the walls thereof.

4. In a catheter as set forth in claim 3, said annular wall including a reservoir at the proximal end thereof that surrounds said body and in which a liquid is c011- tained, said liquid being forced into the distal end of said annular wall to distend said balloon section upon the application of pressure to said reservoir, and means for retaining said reservoir in a compressed position.

5. In a catheter as set forth in claim 3, means for introducing a fluid under pressure into the proximal end of said annular wall, said fluid flowing into the distal end of said annular wall to distend said balloon section.

6. In a surgical accessory, an elongated body having a passage therethrough, an annular flexible wall enveloping the major portion of said body, said annular flexible wall being secured to said body adjacent the distal end thereof and being slidably and sealingly engaged with said body adjacent the proximal end thereof, the portion of said flexible wall adjacent the distal end thereof being distensible for forming an enlarged section when a pressure medium is introduced therein, and means for forcing a pressure medium along the length of said body, between said annular wall and said body and into contact with the distensible portion of said annular wall, said distensible portion being collapsible about the distal end of said body upon removal of said pressure medium therefrom, and said body being slidably removable from a tube in which it has been inserted, the surface tension of said annular wall and the wall in which said body has been inserted restraining said annular wall from initial movement with said body, said annular wall thereafter being peelingly removed from the walls of said tube as the end that is secured to the distal end of said body is withdrawn with said body.

7. In a catheter, an elongated body adapted to be inserted into a tubular element and having a passage formed therein, a flexible member surrounding said body, said member being fixedly secured to said body adjacent the distal end thereof and being slidably and sealingly mounted on the proximal end thereof, the portion of said flexible member adjacent the secured end thereof being distensible under pressure to form a balloon section, and means for introducing a medium under pressure into said distensible portion.

8. In a catheter as set forth in claim 7, said distensible portion being collapsible about the distal end of said body upon removal of said pressure medium therefrom, said body thereafter being slidably removable from said tubular element in which it has been inserted, the intial movement of said body being relative with respect to the major portion of said flexible member, but carrying the secured portion thereof therewith, whereby said flexible member is peeled from engagement with said tubular element as said body is withdrawn therefrom.

9. In a catheter as set forth in claim 8, said flexible member including an annular chamber formed at the proximal end thereof and in which said medium is contained, said annular chamber being deformable to force said medium under pressure toward the distal end of said flexible member and into said distensible portion, said distensible portion thereby being inflated to form said balloon section.

10. In a catheter as set forth in claim 8, means communicating with said flexible member for introducing a medium under pressure into the proximal end thereof, said pressure medium being channeled toward the distal end of said flexible member to distend said balloon section.

Kinney Aug. 3l, 1926 Auzin June 30, 1959 

